PLEASE NOTE: THIS CHAPTER IS STILL UNDER CONSTRUCTION
This chapter contains information from BCAP, Microguide and 3T's but a joint finalised version has yet to be agreed. Please use the information presented here in combination with the appropriate local guidelines.
Paediatric Drugs and the Traffic Light System
This guidance applies:
only where a drug does not already have a TLS classification
only for long-term use of a medicine where the patient would not otherwise visit the initiating clinician or unit at intervals of 60 days or less
Paediatric drugs are frequently used outside the makers Summary of Product Characteristics since many manufacturers fail to conduct the relevant trials needed to secure licensed use in paediatrics. Local guidance has made clear that the BNF for Children is the accepted reference.
In BNF-C for indication and dose range
In BNF-C but outside indications or dose range Not in BNF-C
Licensed drug within SPC indications
Amber No Shared Care Protocol (SCP) needed
Off label use of drug (as per BNF-C definition page 2)
Epistatus® Oromucosal solution prefilled single syringe 10mg/1ml (licensed in adolescents from 10 years to less than 18 years)
Epistatus® Oromucosal solution 10mg/ml prefilled syringes: 2.5mg/0.25ml, 5mg/0.5ml, 7.5mg/0.75ml, (unlicensed). Individually wrapped in a pack of 4.
Do not prescribe Oromucosal solution 10mg/ml multidose 5ml bottle. In primary care, all patients should use the pre-filled syringe format as this is what the specialist primary care nursing team can provide training on for carers/schools/nurseries/after-school clubs etc.
Prescribe by BRAND(NB Buccolam brand is a different salt, STRENGTH and volume)
See Shared Care Guidelines: Use of Oromucosal Midazolam as an intervention for prolonged seizures and prevention od Status Epilepticus in children under 10 years of age
Swindon only - when used for sedation and pre-med in theatres
RED - Hospital only to be prescribed by a specialist and supplied from secondary care ONLY throughout treatment.
Amber medicines are considered suitable for GP prescribing following specialist initiation or recommendation.
Shared Care - these medicines require specialist initiation and stabilisation. Ongoing division of responsibility for drug and disease monitoring between specialist and GP by a Shared Care Guideline (SCG). If no SCG in place status reverts to red.
These medicines are appropriate for initiation in both primary and secondary care. Prescribing is appropriate within licensed or local recommendations.
Suitable for patient to be directed to buy themselves
Not currently used. We intend to include this TLS in future to highlight where a decision to use this medicine is under review.
Not currently used. We intend to include this TLS in future to highlight where a decision has been made by either or both the local or national NHS not to routinely commission this preparation for its licensed indications. Do not prescribe.
Not currently used. We intend to include this TLS in future to highlight where this medicine and indication is ONLY available through a Specialist Centre according to a NICE Highly Specialised Technology or NHSE Specialised Commission Circular / Policy.